ClinicalTrials.gg
CompletedNCT00161746Updated May 21, 2015

Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years

A Phase 2/3 interventional study of Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) in Encephalitis, Tick-borne, sponsored by Pfizer. Completed at 7 sites in Austria. Open to participants aged 6 Months to 47 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-21.

Sponsored by Pfizer · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Allocation
Randomized
Ages
6 Months to 47 Months
Sex
All
01

Study summary

The purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whether there is a difference in terms of safety between the two products.

02

Conditions studied

  • Encephalitis, Tick-borne

Keywords

  • Tick-Borne Encephalitis
03

In context

Encephalitis, Tick-Borne

51 studies on the registry are indexed under Encephalitis, Tick-Borne; 9 are open to participants now.

Browse Encephalitis, Tick-Borne studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 47 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female children aged between 6 and 47 months
  • No history of any previous TBE vaccination
  • Clinically healthy
  • provided by the parents

Exclusion criteria

Exclusion Criteria:

  • History of allergic reactions, in particular allergic reactions to one of the components of the vaccine
  • Suffering from a disease that cannot be effectively treated or stabilised
  • Suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions
  • Suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system
  • -positivity (no special HIV test required for the purpose of the study)
  • Suffering from a febrile disease
  • History of vaccination against yellow fever and/or Japanese encephalitis
  • Participation in another clinical trial
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
06

Study locations

7 sites
  • Wiener Strasse 50/2
    Kapfenberg, 8605, Austria
  • Erzherzog Johann Strasse 9
    Leoben, 8700, Austria
  • Fronleichnamsweg 10
    Liezen, 8940, Austria
  • Hauptstrasse 61
    Linz, 4040, Austria
  • Brauhausgasse 1
    Mürzzuschlag, 8680, Austria
  • Conrad-von-Hötzendorf Strasse
    Voitsberg, 8570, Austria
  • Grieskirchner Strasse 17
    Wels, 4600, Austria
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00161746
Lead sponsor
Pfizer
First posted
Sep 13, 2005
Start date
Apr 1998
Completion
Jun 1999
Last update
May 21, 2015

Study contacts

Baxter BioScience Investigator
principal investigator · Baxter Healthcare Corporation
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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